None listed
Conditions
Brief summary
Dry eye disease causes irritated, burning and gritty eyes and arises commonly from deficient tear film oils (lipid layer) due to blocked eyelid glands (termed meibomian gland dysfunction or MGD). The handheld iLux device delivers a controlled level of heat to the glands to melt the oils, and pressure to express stagnant oils from the glands. This study will compare the magnitude and rate of improvement in tear film quality and dry eye symptoms between the iLux treatment and current standard of care. The targeted heat application with the iLux is hypothesised to result in superior and more rapid improvement in tear film quality and dry eye symptoms than currently recommended treatments.
Interventions
The intervention comprises a single treatment session with the iLux, a hand-held device that utilises thermal pulsation therapy to encourage unblocking of the meibomian glands in evaporative dry eye.
The single treatment session involves up to 30 minutes application of the iLux device by a third-party, unmasked clinically trained investigator, who is uninvolved with research data collection. The clinician accurately positions the device relative to the participant’s eyelid, and applies heat di
The intervention comprises a single treatment session with the iLux, a hand-held device that utilises thermal pulsation therapy to encourage unblocking of the meibomian glands in evaporative dry eye. The single treatment session involves up to 30 minutes application of the iLux device by a third-party, unmasked clinically trained investigator, who is uninvolved with research data collection. The clinician accurately positions the device relative to the participant’s eyelid, and applies heat directly to the eyelid, melting the trapped oils within the glands. After warming, focus-guided compressions are performed to encourage release of the melted oils from the glands.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: Participants with symptomatic dry eye due to evaporative causes (e.g. meibomian gland dysfunction). Participants will be required to: • Meet criteria for TFOS DEWS II dry eye diagnosis • Be willing and able to follow the protocol accurately • Be willing to minimise application of dry eye treatments beyond the study treatment Inclusion criteria: • Age 18 years or older, able and willing to comply with study instructions • Minimum of 6 months since onset of self-reported dry eye symptoms • Normal lid architecture, and closure • Dry eye diagnosis according to the TFOS DEWS II diagnostic criteria (Symptoms: DEQ5 equal or greater than 6, or OSDI equal or greater than 13. Signs: equal or greater than 1 positive finding on NIKBUT (less than 10 s) / osmolarity (equal or greater than 308mOsm/L or interocular difference of greater than 8mOsm/L) / staining (greater than 5 corneal spots, 9 conjunctival spots; or lid wiper epitheliopathy of equal or greater than 2mm length and equal or greater than 25% lid margin width) • Evidence of meibomian gland dysfunction (lipid layer grade equal or less than 2, meibomian gland capping grade equal or greater than 1, and/or meibomian gland expressibility score of equal or greater than grade 2)
Exclusion criteria
Exclusion criteria: • Patients with a small interpalpebral fissure unable to house the The Smart Tip Patient Interface • Patients whose pupils have been pharmaceutically dilated, since the aversion response (i.e., rapid pupil constriction) may be diminished. • Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye. • Inability or unwillingness to commit to 6-month trial • Refusal or inability to refrain from topical eye drop use, including artificial tear supplements, for equal or greater than 48 hours prior to baseline visit or within 24 hours of any subsequent study visit • Refusal to limit topical supplement use to ‘rescue use’ only • Refusal to be advised of incidental findings • Wear of contact lenses within 48 hours of study commencement or during the study • Warm compress therapy within 30 days of the screening visit • Prior iLux or Lipiflow treatment • Punctal plugs, unless non-dissolvable (silicone plugs or cautery of equal or greater than 3 months duration) • History of ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of the screening visit • History or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety. This includes but is not limited to significantly reduced visual acuity (equal or less than 20/200), significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection or inflammation unrelated to dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection • Use of topical medications that might interfere with the study outcomes, or deemed to be contraindicated for participation • A systemic condition or disease considered unstable or judged by the investigator to be incompatible with participation in the study (including but not limited to current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction) • Self-reported pregnancy or lactation • Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment (with antihistamines, decongestants, oral or aerosol steroids) at the time of screening • Use of medication known to cause ocular drying (including but not limited to antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids) within 30 days of the screening visit • Use of oral medications not associated with ocular drying, unless stable dose for equal or greater than 3 months and continued at the same dose throughout trial • Participation in any clinical trial with a new active substance or a new device within 30 days of the screening visit
Outcome results
None listed